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510(k) K250741

Evidence MultiSTAT DOA Urine MultiPlex by Randox Laboratories Limited — Product Code DJG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 23, 2026
Date Received
March 11, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Opiates
Device Class
Class II
Regulation Number
862.3650
Review Panel
TX
Submission Type

Other clearances by Randox Laboratories Limited

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  • K152343 — Direct Bilirubin (February 16, 2016)
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  • K150819 — Triglycerides (August 6, 2015)
  • K140971 — LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3. (December 8, 2014)
  • K142181 — RANDOX ALDOLASE CALIBRATION SERUM (September 18, 2014)
  • K140522 — RANDOX IMMUNOASSAY PREMIUM PLUS CONTROL LEVELS 1,2 AND LEVEL 3 AND IMMUNOASSAY P (May 22, 2014)

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